Reported Sep 25, 2013 · Terminated
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture…
Smith & Nephew, Inc. Endoscopy Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew, Inc. Endoscopy Division · 150 Minuteman Drive · Andover, MA · 01810-1031
Is this the product you have?
- RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles
- Part Number72201805 Biodegradable suture anchor
- Lot codes and dates
5026891850273148502739205027580950275812502821755029165850293289502965255029665050298707503057985030584050312502503125285031483450340632503432035034959150351817503585805037191550376235503878815039036750394081503966395039664050396641503998185040372150405089504122925041552150416545504183335044553350447145504547035045654950460175504601775046171050469565
- Amount recalled
- 1965 US
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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